{
    "info": {
        "nct_id": "NCT02627560",
        "official_title": "The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study",
        "inclusion_criteria": "* breast cancer\n* undergoing unilateral mastectomy with or without axillary node dissection\n* received adequate oral and written information about the study and signed an informed-consent form\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* pregnant or breastfeeding\n* known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure\n* known allergy to tranexamic acid/Cyklokapron®",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* breast cancer",
            "criterions": [
                {
                    "exact_snippets": [
                        "breast cancer"
                    ],
                    "criterion": "breast cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* undergoing unilateral mastectomy with or without axillary node dissection",
            "criterions": [
                {
                    "exact_snippets": [
                        "undergoing unilateral mastectomy"
                    ],
                    "criterion": "unilateral mastectomy",
                    "requirement_type": "procedure",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "with or without axillary node dissection"
                    ],
                    "criterion": "axillary node dissection",
                    "requirement_type": "procedure",
                    "expected_value": "optional"
                }
            ]
        },
        {
            "line": "* received adequate oral and written information about the study and signed an informed-consent form",
            "criterions": [
                {
                    "exact_snippets": [
                        "received adequate oral and written information about the study"
                    ],
                    "criterion": "information about the study",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "signed an informed-consent form"
                    ],
                    "criterion": "informed-consent form",
                    "requirement_type": "signature",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be FEMALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific value",
                    "expected_value": "female"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": [
                        "pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure",
            "criterions": [
                {
                    "exact_snippets": [
                        "known thromboembolic disease"
                    ],
                    "criterion": "thromboembolic disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "high risk of thromboembolism"
                    ],
                    "criterion": "thromboembolism",
                    "requirement_type": "risk level",
                    "expected_value": "high"
                }
            ]
        },
        {
            "line": "* known allergy to tranexamic acid/Cyklokapron®",
            "criterions": [
                {
                    "exact_snippets": [
                        "known allergy to tranexamic acid"
                    ],
                    "criterion": "tranexamic acid allergy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "known allergy to",
                        "Cyklokapron®"
                    ],
                    "criterion": "Cyklokapron® allergy",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}